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A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856917
Recruitment Status : Completed
First Posted : April 23, 2021
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Brief Summary:
Efficacy and Safety of Imsidolimab in Subjects with Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Imsidolimab Biological: Placebo Phase 2

Detailed Description:
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imsidolimab in adolescent and adult subjects with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of Imsidolimab and explore the immune response to Imsidolimab in subjects with AV.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Acne Vulgaris
Actual Study Start Date : May 15, 2021
Actual Primary Completion Date : February 1, 2022
Actual Study Completion Date : March 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: High Dose Arm: Imsidolimab Biological humanized antibody Drug: Imsidolimab
Humanized Monoclonal Antibody
Other Name: ANB019

Experimental: Low Dose Arm: Imsidolimab Biological humanized antibody Drug: Imsidolimab
Humanized Monoclonal Antibody
Other Name: ANB019

Placebo Comparator: Placebo Biological: Placebo
Placebo




Primary Outcome Measures :
  1. To determine the effect of Imsidolimab compared with placebo change from baseline in facial inflammatory lesion count at week 12. [ Time Frame: Change from baseline in facial inflammatory lesion count at week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to sever facial acne vulgaris
  • Facial IGA score of 3 (moderate) or 4 (severe)
  • At least 20 and no more than 100 inflammatory lesions on the face
  • No more than 100 noninflammatory lesions on the face.
  • No more than 5 nodules (≥5 mm) on the face

Exclusion Criteria:

  • A subject with acne fulminans or conglobate or secondary acne will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856917


Locations
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United States, Arkansas
Site 10-114
Hot Springs, Arkansas, United States, 71913
United States, California
Site 10-111
Fountain Valley, California, United States, 92708
Site 10-106
Sherman Oaks, California, United States, 91403
United States, Florida
Site 10-113
Sweetwater, Florida, United States, 33172
Site 10-108
Tampa, Florida, United States, 33607
Site 10-107
Tampa, Florida, United States, 33613
United States, Louisiana
Site 10-109
New Orleans, Louisiana, United States, 70119
Site 10-112
New Orleans, Louisiana, United States, 70119
United States, Michigan
Site 10-104
Detroit, Michigan, United States, 48202
United States, New Hampshire
Site 10-110
Portsmouth, New Hampshire, United States, 03801
United States, Tennessee
Site 10-105
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Site 10-103
Austin, Texas, United States, 78759
Site 10-102
College Station, Texas, United States, 77845
Site 10-101
San Antonio, Texas, United States, 78213
Canada, Ontario
Site 10-115
Waterloo, Ontario, Canada, N2J1C4
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: Bruce Randazzo, MD AnaptysBio, Inc.
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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT04856917    
Other Study ID Numbers: ANB019-209
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnaptysBio, Inc.:
LI-36 Receptor
Interleukin 36
Imsidolimab
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases